Prostate cancer (PCa) is the second most common cancer in men, and is one of the leading causes of mortality and results in momentous public health impact in many developed countries, including many Western European nations and the United States.
PCa is a disease of increasing significance worldwide. No exception is Hong Kong in this public health issue. With reference to the statistics of Hong Kong Cancer Registry, Hospital Authority, HKSAR, PCa ranked 3rd for the most common cancers in men and 5th for the most fatal cancers. Given the latency of early, treatable PCa and the lethality of its late and discernible stage, there is an urgent need for more sensitive and accurate diagnostic methods to detect early stage PCa, so that treatment outcome can be significantly improved with more lives being saved.
Current diagnosis of PCa relies on digital rectal examination (DRE) and serum prostate specific antigen (PSA) test, followed by transrectal ultrasound prostatic biopsy (TRUSPB) confirmation. Although DRE is a simple procedure, it causes discomfort to patients. DRE is also a strong-investigator-dependent technique, which results in poor accuracy for PCa diagnosis. In particular, DRE is not a good tool for the early detection of PCa, because most DRE positive PCa results are of advanced staging. Although the PSA test shows good sensitivity in detecting early stage PCa, elevated PSA levels have also been observed in patients with benign prostatic hyperplasia (BPH) and prostatitis, etc., which decreases the specificity of PSA for PCa.
Within the grey zone of the PSA test, the positive-predictive value has a small mean value of 21%. A wide variety of PSA methodologies, such as the PSA density of transition zone, free/total PSA ratio, p2PSA and Prostate Health Index have been developed to improve the performance of PSA measurement.
Transrectal ultrasonography guided prostate biopsy (TRUSPB) is currently the most common diagnostic approach for histological confirmation of PCa diasnosis. However, this procedure is very labor intensive and leads to significant discomfort and complications to patients.
As a result of the poor specificity of serum PSA test, many patients without PCa are subjected to TRUSPB and thus its potential complications. It is therefore essential to develop a more efficient detection kit for accurate, early stage PCa screening.
It is an objective of the present disclosure to provide a method for diagnosing PCa in a patient comprising detecting one or more urinary polyamines (such as, putrescine (Put), spermindine (Spd) and/or spermine (Spm)). The urinary polyamines are useful as biomarkers for PCa detection. The diagnostic power of the urinary polyamines was identified by comparing urinary polyamine concentrations in patients diagnosed with PCa, patients diagnosed with benign prostatic hyperplasia (BPH) and healthy controls (HC). Also provided herein are compositions and methods useful for detecting and quantifying the amount of the urinary polyamines in a patient.